OcuLight SLx Tri-Mode Console 115V 13030Recalls & reported problems
Iridex Corporation · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00813125016289), received between Jun 14, 2024 and Jun 14, 2024 — classified as 1 injury.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Insufficient Device Problem Information1
Patient problems
- Eye Injury1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJun 14, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
A PATIENT EXPERIENCED AN INJURY WHILE BEING TREATED WITH IRIDEX OCULIGHT SLX LASER SYSTEM. THE PROBE WAS DISCARDED. NO OTHER INFORMATION WAS PROVIDED ON THE REPORTED ADVERSE EVENT. IT IS UNKNOWN IF THE DEVICE MALFUNCTIONED. THEREFORE, GIVEN TO THE LIMITED INFORMATION IT IS UNKNOWN WHETHER THE DEVICE PERFORMANCE MAY HAVE LED TO THE PATIENT INJURY. IRIDEX IS CURRENTLY INVESTIGATING THIS ADVERSE EVENT AND HAS CONTACTED THE COMPLAINANT TO GATHER MORE INFORMATION.
Patient problems: Eye Injury
MAUDE report 19538827 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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